Kornimate/medical-research-clean huggingface dataset:
a study to compare 3 doses of a hormonal intra-uterine device containing levonorgestrel and indomethacin with a hormonal intra-uterine device containing only levonorgestrel to assess the effect and safety of the combined components

Conditions: Contraception

Summary: this study is the first study investigating the combined intrauterine administration of lng (levonorgestrel) and ind (indomethacin). it is a combined proof-of-concept (poc) and dose finding (df) study in pre-menopausal women. it is designed to investigate the pharmacodynamics (pd) of bay 987443 (i.e. ius (intrauterine system) releasing lng and ind), as well as pharmacokinetics (pk) of both active substances, safety and tolerability. in this study, jaydess, as an lng-only ius, will be used as a comparator.


Eligibility criteria:
inclusion criteria: * agreement to use an acceptable non-hormonal method of contraception (i.e. male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) when sexually active. this applies during the pre-treatment cycle and directly following the treatment period until the end of the follow-up period. this is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s). * age at screening: 18-45 years inclusive * body mass index (bmi) at screening: ≥ 18 and ≤ 32 kg/m² * no clinically relevant abnormal findings in the pre-treatment endometrial biopsy * adequate venous access (for frequent blood sampling) exclusion criteria: * menstrual disorders with unknown reason (not e.g. oligomenorrhea, hypomenorrhea amenorrhea due to hormonal treatment; not irregularities occurring during menarche). in case it is suspected that the woman is peri-menopausal, she should be excluded. * use of short-acting hormonal contraceptives/preparations containing sex hormones (oral, transdermal, intravaginal, ius) during the pretreatment cycle * use of long-acting preparations containing sex hormones within the 40 weeks before the first screening examination (any long-acting injectable or implant) * history of known or presence of suspected or known malignant tumors, especially any breast cancer, cervical carcinoma in situ or other progestin-sensitive cancer * history of skin reactions, or other allergic-type reactions or known hypersensitivity reactions after taking aspirin, ind or other nsaids or to lng, or any excipients of the iuss * regular use of corticosteroids, irrespective of route of administration * known asthma bronchiale and aspirin-sensitive asthma * current or recurrent pelvic inflammatory disease * abnormal cervical smear within the last 6 month prior to screening * acute genital infection * known current thyroid disorders which require treatment (subjects with an euthyroid struma who do not need any treatment can participate)
tamoxifen citrate decision aids for women at increased risk of breast cancer

Conditions: Breast Cancer

Summary: rationale: evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer. purpose: this randomized phase i/ii trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.

objectives: * to develop and test a decision aid for describing the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast cancer. outline: * phase i: patients are randomized to view 1 of 16 decision aids that vary in terms of how the information is presented based on 5 dimensions: 1) statistical information in pictographs vs plain text, 2) risk information presented with denominators of 100 vs 1000, 3) risk information presented in terms of total vs additional risk, 4) whether the risks of tamoxifen citrate are presented before or after the benefits are presented, and 5) contextual information about other risks the patient faces (all cause mortality, colon cancer, heart attack). patients complete baseline and post-test questionnaires. * phase ii: patients are randomized to 1 of 3 arms. * arm i (control): patients do not view the decision aid, but complete baseline and post-test questionnaires. * arm ii (control): patients complete a baseline questionnaire only. they do not view the decision aid or complete the post-test questionnaire. * arm iii (intervention): patients view 1 of 16 decision aids that vary based on 5 factors: 1) providing (or not) comparative information about the average woman's breast cancer risk, 2) sequencing presentation of risks and benefits (risks first vs benefits first), 3) including (or not) a summary table following presentation of risks and benefits, 4) using second vs third person language ("your risk" vs "a person like you"), and 5) presenting the decision as having 2 vs 3 options (taking/not taking a breast cancer prevention drug vs taking tamoxifen citrate/raloxifene, or no drug). patients also complete baseline and post-test questionnaires. patients in both phases complete an online follow-up survey at 3 months. patients in arms i or ii (of phase ii) receive a decision aid after completion of the follow-up survey.

Eligibility criteria:
disease characteristics: * believed to be at increased risk of breast cancer (risk of ≥ 1.66% over 5 years) according to electronic-based medical data patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: breast cancer
the effect of chinese herbal medicine for reducing the application of antibiotics in the treatment of acute mastitis

Conditions: Mastitis Acute Female

Summary: the object of the study is to evaluate the effect of pugongying (herba taraxaci) granules to reduce the application of antibiotics for women with acute mastitis.

acute mastitis affects the health and quality of life of the infants and mothers during the lactation. increasing studies indicate that bacterial infections and/or dysbacteriosis are essential to the mechanisms of the disease. thus, antibiotics is widely used in clinical practice, especially cephalosporin in china. however, mistaking antibiotic will affect the physical function, even mothers' breastfeeding. the previous clinical trial that the investigators had conducted in the third affiliated hospital of beijing university of chinese medicine, has demonstrated that chinese herbal medicine can act better than cefdinir in the fever-relief time and breast pain scores. some studies the investigators searched in the databases have showed that pugongying (herba taraxaci) has a broad spectrum of antimicrobial activity, and it can regulate dysbacteriosis. at the same time, pugongying (herba taraxaci) can also promote the secretion of milk and maintain the patency of milk well. the main ingredient of pugongying (herba taraxaci) granules is pugongying herbs (herba taraxaci). pugongying (herba taraxaci) granules is approved by china food and drug administration (cfda) to treat acute mastitis. although pugongying (herba taraxaci) granules is widely used in clinical practice, there is no trial to test the efficacy of pugongying (herba taraxaci) for women with acute mastitis. therefore, the investigators set three groups with pugongying (herba taraxaci) granules alone, cefdinir alone and combination of pugongying (herba taraxaci) granules and cefdinir.

Eligibility criteria:
inclusion criteria: 1. women in lactation who have strong willing to breastfeeding; 2. the course of acute mastitis should be within 3 days, and the ultrasound examination indicates there is no abscess cavity formed; 3. the body temperature is higher than 37.2°c but lower than 41°c; 4. the vas scores of participants≥4; 5. patients with acute mastitis have not received other medical therapies; 6. those who have signed informed consent. exclusion criteria: 1. participants who suffered nipple ulceration, painful fissuring or developmental defects fail to breastfeed; 2. participants with other breast diseases are not appropriate to breastfeed; 3. participants with severe cognitive or metabolic diseases will affect breastfeeding; 4. participants who have been allergic to penicillin and cephalosporin.

Keywords: pugongying herba taraxaci acute mastitis cefdinir randomized controlled trial postpartum breastfeeding lactation multicenter chinese herb traditional chinese medicine cephalosporin antibiotics
supplemented very low protein diet and the progression of chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: this is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (ckd) in patients with advanced ckd.

all eligible patients who will give informed consent will be screened. those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional lpd will be prescribed in all patients. at the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the kd or to continue the conventional lpd for a total duration of 15 months. nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. the laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum c-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin). the anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter. the compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter. the blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.

Eligibility criteria:
inclusion criteria: * adult non-diabetic patients * stage 4-5 ckd not on dialysis (estimated glomerular filtration by modification of diet in renal disease formula \< 30 ml/min per year * stable renal function at least 12 weeks before enrollment * well-controlled arterial blood pressure * proteinuria less than 1 g/g urinary creatinine * good nutritional status * declared and anticipated good compliance with the prescribed diet exclusion criteria: * poorly controlled arterial blood pressure (≥145/85 mm hg) * relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy) * uremic complications (pericarditis, polyneuropathy) * feeding inability (anorexia, nausea)

Keywords: chronic kidney disease restricted protein diets nutritional status
nutritional supplement for patients with severe infection

Conditions: Severe Infection

Summary: this is a randomized trial testing a supplement that has been approved by health canada to support healthy cholesterol levels (i.e. high density lipoprotein (hdl) cholesterol). this trial is proposing to use this approved supplement to determine whether it is able to raise hdl cholesterol in patients treated in the intensive care unit (icu) with severe infection who have detrimentally low levels of hdl cholesterol. patients who present to the icu with severe infection will be approached for consent. if they choose to participate, patients will be given usual care or a 150ml daily nutritional supplement containing lauric acid (15 ml) and berberine (1000 mg) daily for 14 days. participants will be followed during their stay in the icu and will receive follow up phone calls at day 28 and 90.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sepsis * plasma high density lipoprotein levels less than 1 mm * receiving enteral nutrition exclusion criteria: • known pregnancy/intending to get pregnant within 28 days of enrollment in study

Keywords: dyslipidemia
consistency of questionnaires to evaluating sexual functions in young healthy women

Conditions: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Physical Activity

Summary: the sample comprised 31 female undergraduate students attending a private university in joão pessoa, northeastern brazil. the inclusion criteria were: age between 19 and 35 years, heterosexual, active sex life, living in a stable relationship for at least 6 months no pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms for participating in the study. all participants gave their informed consent to take part in the study.

purpose: to compare the consistency of 3 instruments for sexual function evaluation in healthy young women before and after a pelvic floor muscle training. methods: thirty-one healthy young women were enrolled in an 8-week training program, consisting of bipedal exercises performed at home. the perfect and peritron methods were used to estimate the efficacy of the intervention on pelvic muscles. three questionnaires (fsfi, sq-f and griss) were applied to assess sexual function. both procedures were performed on three occasions: before, 4 and 8 weeks after the start of the training program. anova for repeat measures and tukey's post hoc were applied to analyze perfect and peritron results, as well as individual domains and total scores of the questionnaires. the accuracy measured by the area under the roc curve (auc) for individual domains of each questionnaire and cross-validated pairwise comparison of the three instruments were also analyzed.

Eligibility criteria:
inclusion criteria: * age between 19 and 35 years; * heterosexual with active sex life, living in a stable relationship for at least 6 months; * no pregnancy or parturition in the last 6 months; * clinically healthy; * agreeing with the terms for participating in the study; * to sign and agree with their informed consent to take part in the study. exclusion criteria: - do not continue with the intervention program.

Keywords: pelvic floor muscles physical therapy sexual function evaluation
sarcopenia and osteopenia in individuals with cerebral palsy and influences after botulinum neurotoxin type a injection

Conditions: Cerebral Palsy

Summary: botulinum neurotoxin type a (bont-a) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. however, bont-a injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. there are some objectives of this research. the first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. to confirm the influences of intramuscular administration of botox on muscular and bony health in this population is the other aim.

individuals with cerebral palsy is vulnerable to osteopenia and sarcopenia. botulinum neurotoxin type a (bont-a) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. however, bont-a injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. there are some objectives of this research. the first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. to confirm the influences of intramuscular administration of botox on muscular and bony health in this population is the other aim.

Eligibility criteria:
inclusion criteria: 1. diagnosis of spastic cp (cerebral palsy) 2. moderate to severe spasticity over the limbs, modified ashworth scale score≧2 exclusion criteria: 1. fixed contractures of the limbs 2. previous musculoskeletal surgery on the limbs 3. contraindications to botulinum toxin intervention
peep levels on intraabdominal pressure and hemodynamics in critically ill patients

Conditions: Intraabdominal Hypertension; Critically Ill; Hemodynamic Instability

Summary: in this study, it was aimed to compare the effects of three different peep levels (0-4, 5-8, 9-12 cmh2o) on intraabdominal pressure and hemodynamic parameters of patients in intensive care unit.

patients between 18-80 years old whom were mechanically ventilated without any spontaneous respiratory efforts on supine position were included into the study. bladder pressure measurement as a practical and frequently preferred method was used in order to measure intra-abdominal pressure. 100 ml isotonic fluid was given during the measurement. level of symphysis pubis was chosen for zeroing the pressure transducer to measure the intra-abdominal pressure. three patient groups, each containing 22 cases, totally 66 patients were planned in this study. all patients were mechanically ventilated with various peep levels. the patients with 0-4 cmh2o peep levels were named group 4; the patients with 5-8 cmh2o peep levels were named group 8; the patients with 9-12 cmh2o peep levels were named group 12. the levels of patients' peep levels were arranged by the responsible intensive care physician regarding to the patients' clinic. intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.

Eligibility criteria:
inclusion criteria: * age between 18-80, * connected to mechanical ventilator in intensive care, * had not undergone surgery of the abdomen, * patients followed at the same peep levels for at least 24 hours exclusion criteria: * the consent for the study, * initial intrabdominal pressure level is over 12 cmh2o, * undergoing abdominal surgery or bladder surgery, * neurogenic bladder, * morbid obesity, * chronic obstructive pulmonary disease patients were excluded from the study.

Keywords: critically ill patients intraabdominal pressure hemodynamics positive end-expiratory pressure
resure sealant pivotal study

Conditions: Cataract Surgery Incision Leak

Summary: this is a randomized multicenter study to evaluate the safety and effectiveness of resure sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.


Eligibility criteria:
inclusion criteria: * subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens * subject must be 22 years of age or older exclusion criteria: * any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment * previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

Keywords: cataract surgery
treatment of chronic urticarial unresponsive to h1-antihistamines with an anti-il5ralpha monoclonal antibody

Conditions: Chronic Idiopathic Urticaria

Summary: study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. the study also involved blood draws and a punch biopsy of a hive

Eligibility criteria:
inclusion criteria: * hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines exclusion criteria: * hives due to known reasons history of cancer pregnant or nursing history of hiv or hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody
microbiome translocation in different circulatory compartments in decompensated cirrhosis

Conditions: Cirrhosis, Liver

Summary: acquired dysfunctional immunity in cirrhosis predisposes patients to frequent bacterial infections contributing to disease progression and may lead to the development of acute-on-chronic liver failure (aclf). spontaneous bacterial peritonitis (sbp) is one of the most frequent infections in cirrhosis and therefore a trigger for aclf. aclf is characterized by systemic inflammation even in the absence of confirmed infection and associated with poor outcome. the source of ascites infection, especially in case of culture-positive sbp and bacterascites, is suspected to be bacterial translocation from gut. in decompensated cirrhosis, data on the gut microbial translocation in different circulatory compartments is limited. moreover, the link between gut microbiome and systemic inflammation in liver disease has still not established. the transjugular intrahepatic portosystemic shunt (tips) is applied to treat portal hypertension which frequently leads to intestinal bleeding, life-threatening esophageal bleeding and ascites. under the procedure of tips, the vein blood samples in different compartments (superior mesenteric vein, portal vein and hepatic vein) from patients with decompensated liver cirrhosis are available. metagenomic next-generation sequencing (mngs) is a promise approach for the diagnosis of infectious disease because a comprehensive spectrum of potential causes (viral, bacterial, fungal, and parasitic) can be identified by a single assay. previous study reported that mngs of cerebrospinal fluid can be applied to diagnosis of meningitis and encephalitis. comparing to traditional bacterial culture method, mngs method is more sensitive and rapidly in pathogen detection. therefore, the circulating microbiome in different compartment can be characterized by means of mngs. here, the study aim to investigate the circulating microbiome from superior mesenteric vein (first venous outflow in gut-liver axis), hepatic vein (liver outflow), peripheral vein and ascites from patients with decompensated liver cirrhosis receiving tips. before tips, fecal sample and unary sample are collected. and mngs method is performed to identify the pathogen in ascites,fecal and blood samples in a single center. ultimately, the study aim to build up the link between gut microbiome translocation and liver disease.


Eligibility criteria:
inclusion criteria: 1. age\>18 years old; 2. patients with decompensated liver cirrhosis; 3. patients receiving tips for either variceal bleeding or refractory ascites. exclusion criteria: 1. hepatic tumor or extrahepatic related cancer; 2. not provide written consent.

Keywords: gut microbial translocation metagenomic next-generation sequencing transjugular intrahepatic portosystemic shunt
a trial to assess the efficacy and safety of spm 927 (lacosamide) in subjects with painful distal diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: this trial was conducted at about 50 sites in europe and has been clinically completed. patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. after a 2-week run-in phase patients were randomly assigned to one of three treatment arms. all patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. at the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. the change in pain was measured daily as well as interference of pain with sleep and general activity.


Eligibility criteria:
inclusion criteria: * painful distal diabetic neuropathy exclusion criteria: * symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years

Keywords: painful distal diabetic neuropathy